3M -1243 A/B Comply Steam Chemical Integrator Indicators

Chemical Indicator Types

3M™ Attest™ Steam Chemical Integrators meet the requirements of ISO 11140-1:2014 for Type 5 Integrating Indicators. These indicators are designed to monitor all three of the critical variables of the steam sterilization process (time, temperature and steam) across full range of steam sterilization temperature use.

Third Party Testing

As part of our compliance process, 3M hired BSI, a leading global independent product testing services company, to confirm that 3M™ Attest™ Steam Chemical Integrators meet the Type 5 Integrating Indicator performance requirements of ISO 11140-1:2014.
Through rigorous product testing, BSI confirmed these products meet the performance requirements of ISO 11140-1:2014. A copy of the BSI Kitemark™ Certification is available upon request from 3M.

Performance Characteristics

The 3M™ Attest™ Steam Chemical Integrator has been tested at various time and temperature intervals in saturated steam in a test vessel (called a resistometer) to determine compliance to the chemical indicator standards listed in the Chemical Indicator Types
section above. To meet the Type 5 Integrating Indicator performance standards, the 3M™ Attest™ Steam Chemical Integrator must have a response that correlates to the performance of a BI at three temperatures (121°C/250°F, 135°C/275°F, and one or more equally spaced temperature points in the range of 121°C/250°F to 135°C/275°F, such as 128°C/263°F).7 These responses are called Stated Values. Stated Values are “value or values of a critical process variable at which the indicator is designed to reach its endpoint as defined by the manufacturer.”7 In addition, the Stated Value at 121°C/250°F must be >16.5 minutes and the 135°C/275°F stated value must be >1.2 minutes.7

These are the most important Stated Values to ensure that chemical indicators labeled for use in 132°C/270°F do not change too quickly or inappropriately at lower and higher temperatures (to ensure the performance of the CI is consistent between all temperatures)
and to ensure that all temperatures correlate to the performance of a BI. Furthermore, all of the ISO 11140 1:2014 Type 5 performance requirements must be met to ensure that the CI can detect improper sterilization conditions inside of each pack/container. Figure 1
shows three typical Stated Values for the 3M™ Attest™ Steam Chemical Integrators.

Instructions For Use

Placement and Processing

1. Carefully tear or use scissors at the tear notch at the top of the foil package to make the initial opening. Remove only the number of          3M™ Attest™ Steam Chemical Integrators needed. Reseal the package.
2. Place a 3M™ Attest™ Steam Chemical Integrator in each pack, peel pouch, container system or tray to be steam sterilized in the              area  determined to be the least accessible to steam penetration.
3. Process the load according to established procedures.

Note: Refer to the package insert for a complete set of instructions.

After processing, the dark color should have entered the ACCEPT window of the 3M™ Attest™ Steam Chemical Integrators 1243A, 1243B and 1243RE. If the dark color has not entered the ACCEPT window, this indicates a REJECT result which means that the items
in the pack, peel pouch, container system, or tray were not exposed to sufficient steam sterilization conditions. These items should be returned for reprocessing.

Safety

The design of the 3M™ Attest™ Steam Chemical Integrator prevents the indicating chemicals of the CI from coming in contact with sterilized materials or personnel handling the device. The chemical, as a pellet before processing or as a melted color front after processing, is contained in an envelope of impermeable top and bottom layers.

Storage and Shelf Life

• Best stored at normal room temperature conditions, 15–30ºC (59–86ºF) and 40–60% relative humidity. Store away from direct sunlight.    Do not store near strong alkaline or acidic products such as cleaning/disinfecting agents.
• After use, the indicator will not change visually within 6 months when stored at above conditions.
• 3M™ Attest™ Steam Chemical Integrators contained in an unopened package have a shelf life as labeled from date of manufacture        when stored at recommended conditions. The expiration date is printed on the package label and is also contained in the barcode on        each device.

Packaging

100 per Bag, 500 per Bag

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